“This is the next step allowing us to gather data to understand the safety and immunogenicity of the vaccine,” Pfizer said.
New Delhi: Pfizer on Tuesday (June 8, 2021) announced that it is expanding testing of its COVID-19 vaccine in kids under 12 years of age. Pfizer said that they are beginning Phase 2/3 part of their continuous study of their COVID-19 vaccine in healthy children.
“This is the next step allowing us to gather data to understand the safety and immunogenicity of the vaccine in this group aged 5–11 years,” Pfizer said.
The American company said that the Phase 1/2/3 dose-escalation study in children will evaluate the tolerability of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) in three age groups:
1) Children aged 5 to 11 years.
2) 2 to 5 years.
3) 6 months to 2 years.
Pfizer will enrol over 4,500 children (6 months to 11 years old) in the United States, Finland, Poland and Spain at more than 90 clinical trial sites.
“Children younger than 6 months of age may subsequently be evaluated, once an acceptable safety profile has been established,” Pfizer said.
They added, “Children under the age of 15 account for 26% of the global population. We believe successfully vaccinating children will contribute to protection against COVID-19 if the vaccine proves to be effective in that population.”
As per reports, 5 to 11-year-olds will receive two vaccine doses of 10 micrograms each – a third of the teen and adult dose – or dummy shots. Whereas, children as young as 6 months will be given lower dose, 3 micrograms per shot.
This is to be noted that the vaccine made by Pfizer and its German partner BioNTech is already authorised for emergency use in anyone 12 and older in the United States and the European Union.
Meanwhile, as per the World Health Organization (WHO), there have been 17,33,31,478 confirmed cases of COVID-19 globally, including 3,735,571 deaths. On the other hand, as of June 7, a total of 2,09,28,63,229 coronavirus vaccine doses have been administered across the world.
